A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 29
- 主要终点
- Total UPDRS I, II, III Scores
研究概览
简要总结
This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and rasagiline for the treatment of early Parkinson's disease.
Animal studies support the therapeutic advantage of combining low doses of rasagiline and pramipexole and suggest further improvement when both are administered in a sustained fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's disease with a good safety profile. combining the drugs in low doses and controlled release may provide better symptom management than the existing drugs alone or together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
- •Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
- •Subject with disease duration no longer than 3 years and 0 months.
- •Subject has a Hoehn & Yahr (H&Y) stage score of <
- •Subject has a MMSE score ≥ 26
排除标准
- •Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
- •Subject has a history of psychosis or hallucinations within the previous 12 months.
- •Subject who is taking anticholinergic drugs.
- •Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
- •Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
- •Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.
研究组 & 干预措施
Placebo
Placebo once daily for 12 weeks.
干预措施: Placebo (Drug)
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
干预措施: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), (Drug)
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
干预措施: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), (Drug)
结局指标
主要结局
Total UPDRS I, II, III Scores
时间窗: Week 12
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.
次要结局
- UPDRS Motor (Part III)(12 weeks)
- UPDRS ADL (Part II)(Week 12)
- CGI-S(12 weeks)
- PDQ39(12 weeks)